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Epicardial Mitral Touch System for Mitral Insufficiency

NCT04396379 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-01-04

No results posted yet for this study

Summary

To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

Conditions

  • Ischemic Mitral Regurgitation
  • Functional Mitral Regurgitation

Interventions

DEVICE

Implant an epicardial device to reshape the mitral valve annulus

The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Sponsors & Collaborators

  • BSWRI Cardiac Imaging Core Lab (CICL)

    collaborator UNKNOWN

  • Mitre Medical Corp.

    lead INDUSTRY

Principal Investigators

  • Robert L Smith II, MD · Baylor Scott and White Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-10
Primary Completion
2024-12-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396379 on ClinicalTrials.gov